Post-resection adrenocortical carcinoma with high recurrence-risk features — ENSAT stage...

Детермінований перегляд YAML-сутності з джерельної бази. Клінічний авторитет лишається за вказаними source ID та статусом клінічного sign-off.

ID	`RF-ACC-HIGH-RECURRENCE-RISK-BIOLOGY`
Тип	Тривожна ознака
Статус	переглянуто 2026-07-11 \| очікує клінічного підпису
Хвороби	`DIS-ADRENOCORTICAL-CARCINOMA`
Джерела	`SRC-ADIUVO-TERZOLO-2023` `SRC-ENSAT-ACC-2018` `SRC-ESMO-ACC-2020`

Походження тривожної ознаки

Визначення	Post-resection adrenocortical carcinoma with high recurrence-risk features — ENSAT stage III, Ki-67 proliferation index >10%, or incomplete/uncertain (R1/RX) resection margin — defines the population for whom adjuvant mitotane is recommended. The randomized ADIUVO trial found no significant recurrence-free-survival benefit from adjuvant mitotane in the low/intermediate-risk group it enrolled (ENSAT stage I-III, R0 resection, Ki-67 <=10%).
Клінічний напрям	intensify
Категорія	high-risk-biology
Змінює алгоритм	ALGO-ACC-1L

Логіка спрацьовування

{
  "any_of": [
    {
      "finding": "acc_ensat_stage",
      "value": "III"
    },
    {
      "comparator": ">",
      "finding": "ki67_proliferation_index_pct",
      "threshold": 10
    },
    {
      "finding": "resection_margin_status",
      "value": "R1"
    },
    {
      "finding": "resection_margin_status",
      "value": "RX"
    }
  ],
  "type": "composite_clinical"
}

Нотатки

ADIUVO (Terzolo 2023, Lancet Diabetes Endocrinol) defined its low/intermediate-risk enrollment population as ENSAT stage I-III, R0 resection, Ki-67 <=10%, and found no significant recurrence-free- survival benefit from adjuvant mitotane in that population (5-yr RFS 79% mitotane vs 75% surveillance, HR 0.74, not significant). By extension, this RedFlag fires on the features that place a resected patient OUTSIDE the ADIUVO low/intermediate-risk definition: stage III, Ki-67 >10%, or incomplete/uncertain resection margin (R1/RX). This is this KB's first-pass operationalization of "high recurrence risk" for adjuvant mitotane and is STUB / pending clinical co-lead confirmation against the primary ENSAT/ESMO guideline text — those guidelines may specify additional or more granular risk criteria (e.g. tumor rupture, vascular invasion, mitotic count / Weiss-Helsinki score components) not yet encoded here. The finding keys used (acc_ensat_stage, ki67_proliferation_index_pct, resection_margin_status) are newly introduced in this authoring pass and not yet wired to any intake questionnaire — a mechanical/data-availability gap, not a clinical-content gap.

Де використовується

Algorithms

ALGO-ACC-1L - ALGO-ACC-1L

Indications

IND-ACC-1L-RESECTION-MITOTANE - IND-ACC-1L-RESECTION-MITOTANE

Regimens

REG-MITOTANE-ADJUVANT-ACC - Mitotane adjuvant monotherapy (ACC)

Sources

SRC-ADIUVO-TERZOLO-2023 - Adjuvant mitotane versus surveillance in low-grade, localised adrenocortical carcinoma (A...

Препарат

DRUG-MITOTANE - Mitotane